Diabetes mellitus is a disorder of carbohydrate metabolism resulting from insufficient production of, or reduced sensitivity to, insulin. In persons who have diabetes, the normal ability of body cells to use glucose is inhibited, thereby increasing blood sugar levels. As more glucose accumulates in the blood, excess levels of sugar are excreted in the urine. Corresponding symptoms of diabetes include increased urinary volume and frequency, thirst, hunger, weight loss, and weakness.
There are two variations of diabetes. Type 1 diabetes is insulin dependent diabetes mellitus for which insulin administration is required. In a subject patient with type 1 diabetes, insulin is not secreted by the pancreas and therefore must be taken by injection or inhalation. Type 2 diabetes may be controlled by dietary restriction, oral anti-hyperglycemic agents, and/or insulin administration. Type 2 diabetes can be attributable to dilatory pancreatic secretion of insulin and reduced sensitivity to the action of insulin on target tissues. Individuals with diabetes and insulin resistance commonly suffer from muscle loss, muscle wasting, poor muscle quality and strength, and the inability to build new muscle mass in sufficient quantities.
In order to address these muscle wasting and muscle loss issues of diabetics, it is desirable for many diabetics to use, at least in part, nutritional solutions that include one or more protein sources to facilitate and stimulate muscle mass production and strength. Protein-containing nutritional products are available that are designed to increase muscle mass and reduce muscle wasting in individuals. Some of these nutritional products use calcium beta-hydroxy-beta-methylbutyrate (HMB) in combination with protein to further muscle building in the body. HMB is a metabolite of the amino acid leucine, and calcium HMB is the only source of HMB that is Generally Regarded As Safe (GRAS). Nutritional emulsions are particularly useful in this regard because such emulsions may contain a balance of protein, fat, carbohydrates, vitamins, and minerals that is useful for helping build and maintain healthy muscle.
Diabetes is the number one cause of chronic kidney dysfunction (impaired renal function) in individuals and many diabetic individuals also have impaired renal function. Individuals with this condition in later stages of renal failure must be very careful about their total intake of electrolytes such as potassium, sodium, and phosphorus, so as to not overburden their weakened kidneys. As a result, nutritional products including calcium HMB and protein have not been an option for many diabetics. This has been the case to date as nutritionals having calcium HMB and protein have generally required high levels of protein stabilizers, such as organic acid salts including sodium citrates, potassium citrates, sodium phosphates, and potassium phosphates. The high level of protein stabilizers has been required because the combination of calcium HMB and protein systems in liquid nutritionals has proven difficult to effectively stabilize over time as the soluble divalent calcium species in the liquid nutritional, much of which is derived from the calcium HMB, is highly reactive with the protein present in the system and leads to numerous unwanted issues, including undesirably high viscosities, phase separation, and protein aggregation that results in sedimentation, gelation, and/or coagulation defects in the resulting product. This is especially true for non-acidified shelf stable liquid beverages subjected to high heat, such as during a retort sterilization process for microbiological control. As such, without the required protein stabilizers to keep the protein present in the system from reacting with soluble calcium species and precipitating out of solution, a suitable commercial product cannot be formulated.
As such, there is a need for calcium HMB and protein-containing nutritional products, and specifically nutritional liquids, that are stable for a sufficiently long period of time and suitable for use by diabetics and diabetics with chronic kidney dysfunction to build and maintain muscle and muscle mass. Additionally, it would be beneficial if these liquid nutritionals including calcium HMB and protein could have low levels of at least one of potassium, sodium, and phosphorus to assist the user in balancing the dietary intake of electrolytes.